[Federal Register Volume 88, Number 101 (Thursday, May 25, 2023)]
[Notices]
[Pages 33889-33891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11165]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1554]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Generic Clearance for the Collection of Qualitative 
Feedback on Agency Service Delivery

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on a generic collection of 
information through which we intend to seek insights into customer or 
stakeholder perceptions, experiences and expectations, provide an early 
warning of issues with service, or focus attention on areas where 
communication, training, or changes in operations might improve 
delivery of products or services.

DATES: Either electronic or written comments on the collection of 
information must be submitted by July 24, 2023.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of July 24, 2023. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your

[[Page 33890]]

comment does not include any confidential information that you or a 
third party may not wish to be posted, such as medical information, 
your or anyone else's Social Security number, or confidential business 
information, such as a manufacturing process. Please note that if you 
include your name, contact information, or other information that 
identifies you in the body of your comments, that information will be 
posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2023-N-1554 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Generic Clearance for the 
Collection of Qualitative Feedback on Agency Service Delivery.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Generic Clearance for the Collection of Qualitative Feedback on Agency 
Service Delivery

OMB Control Number 0910-0697--Extension

    FDA will garner qualitative customer and stakeholder feedback using 
a variety of methods in order to gain useful insights into customer or 
stakeholder perceptions, experiences, and expectations; provide an 
early warning of issues with service; or focus attention on areas where 
communication, training, or changes in operations might improve 
delivery of products or services. These collections will allow for 
ongoing, collaborative, and actionable communications between the 
Agency and its customers and stakeholders. It will also allow feedback 
to contribute directly to the improvement of program management.
    Feedback collected under this generic clearance will provide useful 
information, but it will not yield data that can be generalized to the 
overall population. This type of generic clearance for qualitative 
information will not be used for quantitative information collections 
that are designed to yield reliably actionable results, such as 
monitoring trends over time or documenting program performance.
    Respondents to this collection of information cover a broad range 
of customers and stakeholders who have specific characteristics related 
to certain products or services regulated by FDA. These stakeholders 
include members of the general public, healthcare professionals, 
industry, and others who have experience with a product under FDA's 
jurisdiction.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 33891]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                 Number of
                  Activity                       Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
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Focus groups................................           3,000               1           3,000  1.75......................................           5,250
Customer comment cards/forms................           1,500               1           1,500  0.25 (15 minutes).........................             375
Small discussion groups.....................             800               1             800  1.75......................................           1,400
Customer satisfaction surveys...............          20,000               1          20,000  0.33 (20 minutes).........................           6,600
Usability studies...........................           1,100               1           1,100  1.........................................           1,100
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................          14,725
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last 
request for OMB approval, we increased the number of respondents for 
focus groups, customer comment cards/forms, customer satisfaction 
surveys, and usability studies. This adjustment results in an overall 
burden increase of 6,234 hours.

    Dated: May 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-11165 Filed 5-24-23; 8:45 am]
BILLING CODE 4164-01-P


